SUPPLY CHAIN ARTICLES
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![GettyImages-1269045566-rna]( "The Expanding Patent Landscape For RNA-Based Therapeutics")
The Expanding Patent Landscape For RNA-Based TherapeuticsThe COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
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![Success Transformation, improvement, leadership-GettyImages-1417761158]( "Beyond The Gold Standard(s): Modernizing Oligonucleotide Synthesis")
Beyond The Gold Standard(s): Modernizing Oligonucleotide SynthesisA few weeks ago, I had the chance to sit down with OPT Congress speaker Phil Baran, Richard Lerner Chair Professor, Department of Chemistry, Scripps Research. Baran was slated to (and did) present a keynote on the innovations shaping the next generation of oligo synthesis. Here, I share the biggest takeaways I had from our conversation, touching on how he sees the science of oligo chemistry and manufacturing advancing in the near and far future.
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![Key takeaways-GettyImages-1659816694]( "Plasmid Production: 3 Key Takeaways For mRNA Manufacturing")
Plasmid Production: 3 Key Takeaways For mRNA ManufacturingFollowing my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid.
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![GettyImages-96831350]( "“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles")
“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP PrinciplesIn the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
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![Helping Hand-GettyImages-1314188794]( "Multidisciplinary mRNA: What Can We Learn From Other CGTs?")
Multidisciplinary mRNA: What Can We Learn From Other CGTs?Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.
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![iStock-1095134748]( "Therapeutic Oligonucleotides: Regulations & Quality Standards")
Therapeutic Oligonucleotides: Regulations & Quality StandardsOligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.
SUPPLY CHAIN VIDEOS
Large scale production of plasmid DNA requires an in-depth understanding and optimization of the entire downstream process. Explore a complete solution, from harvest to bulk filtration.
Three experts in cold chain management walk through the advantages of end-to-end platforms for bulk drug substance management.
In this Advancing RNA Live clip, Khaled Yamout and Sanofi’s Francoise Ribes share the quality considerations that are top of mind when evaluating a novel raw material, as well as how the broader industry (i.e., standard setting organizations, suppliers, and biotechs) can arrive at a clearer understanding of a material’s quality.
Learn more about CustomBiotech's mRNA raw materials pipeline and strict quality criteria that are designed to support the success of our customers’ manufacturing scale-up and regulatory drug approval.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Cryoport]( "Accelerate Your Trials With An End‑To‑End Supply Chain Model")
An end-to-end supply chain model helps clinical trials move faster while maintaining visibility, control, and risk management across complex, temperature‑sensitive, and global operations.
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![mRNA GettyImages-1428646288]( "mRNA Synthesis Reagents And Manufacturing")
As novel mRNA therapies are starting to enter clinical stages of development, Aldevron is providing critical support in a number of ways with specialized products and services.
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![GettyImages-624034258 chemical mixing]( "Demystifying CRISPR gRNA Chemical Modifications")
Chemical modifications on CRISPR gRNAs enhance stability, editing efficiency, and reduce immune responses, enabling in vivo applications and clinical success.
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![Cryoport]( "Why Risk Analysis And Lane Qualification Matter")
Risk analysis and lane qualification show supply chains perform consistently, meeting regulatory expectations by demonstrating control, reducing variability, and ensuring reliable delivery.
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![DNA molecules 450x300]( "Chromatographic Purification Of Plasmid DNA")
Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).
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![GettyImages-1284041821 asian vaccine]( "Revolutionizing Patient-Centric Supply Chains To Improve Vaccine Access")
Transparent collaboration and innovation are essential to establishing an infrastructure that supports more agile business models and empowers widespread vaccine access.
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![iStock-1155553590-syringe-glove-doctor-vaccine-medicine]( "Overcome Vaccine Development Complexities With The Right Supply Chain Partner")
Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.
